Package leaflet: information for the patient

Atorvagen, 10 mg, film-coated tablets
Atorvagen, 20 mg, film-coated tablets
Atorvagen, 40 mg, film-coated tablets
(Atorvastatinum)
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Atorvagen is and what it is used for
Important information before taking Atorvagen
How to take Atorvagen
Possible side effects
How to store Atorvagen
Contents of the pack and other information

1. What Atorvagen is and what it is used for

Atorvagen belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvagen is used to reduce blood levels of lipids known as cholesterol and triglycerides, when diet low in fat and lifestyle changes alone are not effective.
Atorvagen may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range.
Standard low-cholesterol diet should be continued during treatment.

2. Important information before using Atorvagen

When not to use Atorvagen:

if the patient is allergic to atorvastatin or to any other similar medicines used to lower blood lipid levels, or to any of the other ingredients of this medicine (listed in section 6)
if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection
if the patient currently has or has previously had liver disease
if the patient has unexplained abnormal liver function test results
in women of childbearing potential who are not using effective methods of contraception
in pregnant women or women planning to become pregnant
in breastfeeding women

Warnings and precautions
Before starting treatment with Atorvagen, discuss the following with your doctor or pharmacist:

if the patient currently has or has previously had myasthenia (a disease causing general muscle weakness, including in some cases the muscles involved in breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4)
if the patient has severe respiratory insufficiency
if the patient has previously had a stroke or a "mini-stroke" (also called transient ischaemic attack), a stroke with bleeding into the brain, or if there is a small amount of fluid in the brain from a previous stroke
if the patient has kidney problems
if the patient has reduced thyroid gland function (hypothyroidism)
if the patient has previously experienced recurrent unexplained muscle pain or muscle problems, or if such problems occurred in family members
if the patient has previously had muscle problems while being treated with other lipid-lowering medicines (e.g. other statins or fibrates)
if the patient regularly consumes large amounts of alcohol
if the patient has previously had liver disease
in patients over 70 years of age
if the patient is taking or has taken within the last 7 days fusidic acid (a medicine used to treat bacterial infections), either orally or by injection. Concomitant use of fusidic acid and Atorvagen may lead to serious muscle problems (rhabdomyolysis).

If any of the above situations apply to the patient, the doctor will order a blood test
before starting and (whenever possible) during treatment with atorvastatin to assess the risk
of muscle-related adverse reactions. It is known that the risk of muscle-related adverse reactions,
such as rhabdomyolysis, increases when other medicines with similar effects are used concomitantly (see section 2: "Atorvagen with other medicines").
If the patient has diabetes or is at risk of developing diabetes, the patient will be closely monitored by the doctor during treatment with Atorvagen. The risk of developing diabetes is higher
in patients with high levels of blood sugar and fats, overweight patients, and those with high blood pressure.
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.
Atorvagen with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may alter the effect of atorvastatin or their effect on the body may be altered by atorvastatin. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse reactions, including severe muscle damage known as rhabdomyolysis, described in section 4:

immunosuppressive medicines, e.g. cyclosporine
certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin
other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine, niacin
certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone
letermovir, a medicine used to prevent cytomegalovirus disease
medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, delavirdine, efavirenz, saquinavir, the combination of tipranavir/ritonavir, nelfinavir, fosamprenavir, etc.
certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and combination products containing elbasvir with grazoprevir, ledipasvir with sofosbuvir
other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium)
over-the-counter medicines: St John's wort
daptomycin (a medicine used to treat complicated skin and skin tissue infections and bacterial infections in the blood).

If the patient needs to take oral fusidic acid for the treatment of bacterial infections, the patient should temporarily discontinue taking this medicine. The doctor will decide when it is safe to resume treatment with Atorvagen. Concomitant use of Atorvagen with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
Atorvagen, food, drink and alcohol
Information on how to take Atorvagen is provided in section 3. However, please pay attention to the following information:
Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may alter the effect of Atorvagen.
Alcohol
During treatment, avoid consuming excessive amounts of alcohol. Further information on this subject is provided in section 2: "Warnings and precautions".
Pregnancy and breastfeeding
Do not use Atorvagen in women who are pregnant or planning to become pregnant. The use of Atorvagen in women of childbearing potential is contraindicated if they are not using effective methods of contraception.
Do not use Atorvagen during breastfeeding.
The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Atorvagen usually does not affect the ability to drive or operate machinery. However, the patient should not drive if the medicine affects their ability to drive. Do not use any tools or machinery if taking this medicine affects the ability to operate them.
Atorvagen contains lactose and sodium.
Patients who have been advised by their doctor that they have an intolerance to certain sugars should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."

3. How to take Atorvagen

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be
continued during treatment with Atorvagen.
The recommended starting dose of Atorvagen is 10 mg once daily in adults and children aged 10 years and older. This dose may be increased by the doctor as needed to achieve the appropriate dose for the patient. The doctor adjusts the dose at intervals of 4 weeks or longer. The maximum dose of Atorvagen is 80 mg once daily.
Atorvagen tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, it is advisable to take the tablet at the same time each day. Tablets of 20 mg and 40 mg may be divided into equal doses.
The duration of treatment with Atorvagen is determined by the doctor.
If you feel that the effect of Atorvagen is too strong or too weak, consult your doctor.
Taking more Atorvagen than recommended
If you accidentally take too many Atorvagen tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of Atorvagen
If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Atorvagen
If you have any further questions about using this medicine or if you are planning to stop treatment, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions or symptoms, treatment should be discontinued immediately and the patient should contact a doctor or go to the emergency department of the nearest hospital without delay:
Uncommon: may occur in 1 in 100 patients:

inflammation of the pancreas (pancreatitis causing acute abdominal pain radiating to the back);
inflammation of the liver.

Rare: may occur in 1 in 1,000 patients:

severe allergic reaction – symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse;
severe illness characterized by skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters;
muscle weakness, tenderness, muscle pain, muscle rupture, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may indicate rhabdomyolysis (breakdown of striated muscles). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, and may be life-threatening and lead to kidney problems;
obstruction of the bile ducts (cholestasis), which may cause symptoms such as yellowing of the skin or eyes, pain in the upper right part of the abdomen, and loss of appetite.

Very rare: may occur in fewer than 1 in 10,000 patients:

If the patient experiences pain in the upper right part of the abdomen, abdominal swelling, and yellowing of the skin or eyes, this may indicate liver abnormalities. Medical advice should be sought immediately;
lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Frequency unknown: frequency cannot be estimated from available data:

persistent muscle weakness;
myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing);
ocular myasthenia (a disease causing weakness of the eye muscles).

Talk to your doctor if the patient experiences weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible adverse reactions of Atorvagen:
Common (may occur in fewer than 1 in 10 patients):

inflammation of the nasal passages, sore throat, nosebleeds;
allergic reactions;
increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels;
headache;
nausea, constipation, bloating, indigestion, diarrhoea;
joint pain, muscle pain, and back pain, muscle cramps;
blood test results indicating potentially abnormal liver function.

Uncommon (may occur in 1 in 100 patients):

anorexia (loss of appetite), weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored);
nightmares, insomnia;
dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss;
blurred vision;
ringing in the ears and/or in the head;
vomiting, belching, pain in the upper and lower abdomen;
rash, skin rash and itching, urticaria, hair loss;
neck pain, muscle fatigue;
fatigue, malaise, weakness, chest pain, swelling (especially of the ankles), elevated temperature;
presence of white blood cells in urine analysis.

Rare (may occur in 1 in 1,000 patients):

visual disturbances;
unexpected bleeding or bruising (bruises);
tendon rupture;
rash, which may appear on the skin, or oral ulcers (lichenoid drug reaction);
purple skin lesions (symptoms of vasculitis).

Very rare (may occur in fewer than 1 in 10,000 patients):

hearing loss;
gynecomastia (excessive growth of glandular breast tissue in men).

Other possible adverse reactions reported during treatment with some statins (medicines of the same type):

sexual dysfunction;
depression;
breathing problems, including persistent cough and/or shortness of breath or fever;
diabetes: the likelihood of developing diabetes is higher if the patient has high blood sugar and fat levels, overweight, and high blood pressure. During treatment with this medicine, the doctor will carefully monitor the patient.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Atorvagen

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from moisture. There are no special requirements
regarding storage temperature.
Do not use this medicine after the expiry date stated on the carton, label on the bottle, or blister pack after: EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atorvagen contains
The active substance is atorvastatin. Each coated tablet contains 10 mg, 20 mg, or 40 mg of atorvastatin as atorvastatin calcium trihydrate.
The other ingredients in the tablet core are: colloidal anhydrous silica, sodium carbonate, microcrystalline cellulose, L-arginine, lactose, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate. The coating contains: polyvinyl alcohol, titanium dioxide (E 171), talc, and macrogol.

What Atorvagen looks like and contents of the pack
White to off-white, round, film-coated tablets. The 10 mg tablets are marked with "10" on one side, the 20 mg tablets are marked with "20" on one side, and the 40 mg tablets are marked with "40" on one side. The 20 mg and 40 mg tablets have a division line on the other side.
Atorvagen is available in opaque HDPE plastic bottles with PP caps, in cardboard boxes containing 10, 14, 28, 30, 50, 56, 60, 90, 100, 200, 250, or 500 tablets.
Atorvagen is also available in blisters containing 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets, and in calendar packs containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland

Manufacturers
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary
Logiters, Logistica, Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050-306
Portugal
Mylan UK Healthcare Limited
Building 20, Station Close, Potters Bar
EN6 1TL
United Kingdom

For further information about this medicinal product and its trade names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400